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Revista Española de Enfermedades Digestivas

versión impresa ISSN 1130-0108

Rev. esp. enferm. dig. vol.110 no.6 Madrid jun. 2018 


Update of the SEPD position statement on the use of biosimilars for inflammatory bowel disease

Federico Argüelles-Arias1  , Joaquín Hinojosa-del-Val2  , Isabel Vera-Mendoza3 

1Hospital Universitario Virgen Macarena. Sevilla, Spain

2Hospital de Manises. Valencia, Spain

3Hospital Universitario Puerta de Hierro Majadahonda. Madrid, Spain

Key words: Biosimilar; Inflammatory bowel disease; SEPD position statement

Dear Editor,

In 2013, EMA approved the biosimilar of infliximab (CT-P13) for the full range of indications of the originator product, based on data coming from two trials conducted in rheumatoid arthritis and ankylosing spondylitis 1. That year, our Society published a position Statement 2, reviewed later 3.

Since that, many studies in inflammatory bowel diseases (IBD) have been published and have supported the biosimilarity of CT-P13 with the reference product. Recently, a well-known nationwide Norwegian randomised controlled trial 4 on patients with immune-mediated diseases also found no differences in maintenance of remission, or adverse events in patients switched from the reference product versus patients with the reference one. Also, a new ECCO position has been published 5.

Based on these data, the followings statements have been approved:

  1. A biosimilar is a drug that, using molecular biology techniques, has a similar even though not identical structure to the original product, that is intended to provide an action equivalent to that of the product it attempts to copy and requires a complex process based on all the preclinical and clinical trials demanded by European Law.

  2. To obtain license for the treatment of a certain disease, a robust preclinical and clinical trials program must demonstrate biosimilarity with the reference drug.

  3. A license obtained for the management of a certain disease may allows an extrapolation of results to a different disorder, without clinical data, only if the European Medicine Agency considers it based on the results of preclinical trials mentioned previously.

  4. The product label should clearly show the trade name of the biosimilar so that the drug a patient is taking may always be identified.

  5. Based on the data published, the biosimilar CT-P13 presents a good safety and efficacy profile in IBD, both in naïve and switched patients.

  6. The appropriate use of the biosimilar requires always interaction by physicians and patients with the aim of favoring the right to health of patients by offering quality, effective and safe products.

  7. This task force favors the development of biosimilar drugs and therefore their approval by regulatory agencies.


1. European Medicines Agency. CHMP assessment report Remsima (EMA/CHMP/589317/2013). London: EMA, 2013. [ Links ]

2. Argüelles-Arias F, Barreiro-de-Acosta M, Carballo F, et al. Joint position statement by "Sociedad Española de Patología Digestiva" (Spanish Society of Gastroenterology) and "Sociedad Española de Farmacología" (Spanish Society of Pharmacology) on biosimilar therapy for inflammatory bowel disease. Rev Esp Enferm Dig 2013;105(1):37-43. [ Links ]

3. Argüelles-Arias F, Barreiro-de-Acosta M, Carballo F, et al. New contributions to consensus on biosimilars. Rev Esp Enferm Dig 2014;106(3):228-9. [ Links ]

4. Jørgensen KK, Olsen IC, Goll GL, et al. Switching from originator infliximab to biosimilar CT-P13 compared with maintained treatment with originator infliximab (NOR-SWITCH): a 52-week, randomised, double-blind, non-inferiority trial. Lancet 2017;389(10086):2304-16. DOI: 10.1016/S0140-6736(17)30068-5. [ Links ]

5. Danese S, Fiorino G, Raine T, et al. ECCO Position Statement on the Use of Biosimilars for Inflammatory Bowel Disease-An Update. J Crohns Colitis 2017;11(1):26-34. DOI: 10.1093/ecco-jcc/jjw198 [ Links ]

Conflict of interest

Authors have served as a speaker, a consultant and as an advisory member for or have received research funding from Janssen, MSD, Abbvie, Pfizer, Kern Pharma, Biogen, Takeda, Ferring, Faes Farma, Shire Pharmaceuticals, Dr. Falk Pharma, Tillotts Pharma, Gebro Pharma and Vifor Pharma.

Creative Commons License This is an open-access article distributed under the terms of the Creative Commons Attribution License